21 U.S.C. § 358 : US Code - Section 358: Authority to designate official names

Search 21 U.S.C. § 358 : US Code - Section 358: Authority to designate official names

(a) Necessity or desirability; use in official compendiums;
infringement of trademarks
The Secretary may designate an official name for any drug or
device if he determines that such action is necessary or desirable
in the interest of usefulness and simplicity. Any official name
designated under this section for any drug or device shall be the
only official name of that drug or device used in any official
compendium published after such name has been prescribed or for any
other purpose of this chapter. In no event, however, shall the
Secretary establish an official name so as to infringe a valid
trademark.
(b) Review of names in official compendiums
Within a reasonable time after October 10, 1962, and at such
other times as he may deem necessary, the Secretary shall cause a
review to be made of the official names by which drugs are
identified in the official United States Pharmacopoeia, the
official Homoeopathic Pharmacopoeia of the United States, and the
official National Formulary, and all supplements thereto, and at
such times as he may deem necessary shall cause a review to be made
of the official names by which devices are identified in any
official compendium (and all supplements thereto) to determine
whether revision of any of those names is necessary or desirable in
the interest of usefulness and simplicity.
(c) Determinations of complexity, usefulness, multiplicity, or lack
of name; designation by Secretary
Whenever he determines after any such review that (1) any such
official name is unduly complex or is not useful for any other
reason, (2) two or more official names have been applied to a
single drug or device, or to two or more drugs which are identical
in chemical structure and pharmacological action and which are
substantially identical in strength, quality, and purity, or to two
or more devices which are substantially equivalent in design and
purpose or (3) no official name has been applied to a medically
useful drug or device, he shall transmit in writing to the compiler
of each official compendium in which that drug or drugs or device
are identified and recognized his request for the recommendation of
a single official name for such drug or drugs or device which will
have usefulness and simplicity. Whenever such a single official
name has not been recommended within one hundred and eighty days
after such request, or the Secretary determines that any name so
recommended is not useful for any reason, he shall designate a
single official name for such drug or drugs or device. Whenever he
determines that the name so recommended is useful, he shall
designate that name as the official name of such drug or drugs or
device. Such designation shall be made as a regulation upon public
notice and in accordance with the procedure set forth in section
553 of title 5.
(d) Revised official names; compilation, publication, and public
distribution of listings
After each such review, and at such other times as the Secretary
may determine to be necessary or desirable, the Secretary shall
cause to be compiled, published, and publicly distributed a list
which shall list all revised official names of drugs or devices
designated under this section and shall contain such descriptive
and explanatory matter as the Secretary may determine to be
required for the effective use of those names.
(e) Request by compiler of official compendium for designation of
name
Upon a request in writing by any compiler of an official
compendium that the Secretary exercise the authority granted to him
under subsection (a) of this section, he shall upon public notice
and in accordance with the procedure set forth in section 553 of
title 5 designate the official name of the drug or device for which
the request is made.